Vantage Biosciences’ oral diabetic retinopathy drug enters Phase II

Novotech and Icon are running a Phase II study of a candidate oral drug for diabetic retinopathy being developed by Vantage Biosciences.

The study — which started last week — will evaluate VX-01 for non-proliferative diabetic retinopathy (NPDR) at 27 research sites across the US, Australia, and several Southeast Asian countries.

Vantage chairman Alek Safarian told Clinical Insider, “We are working with Novotech and Icon on this study. The choice of CROs was predominantly a factor of expertise in the geographies that Vantage had selected for the study.”

Safarian, who was CEO of Novotech until 2017, told us the choice of trial locations is not indicative of the target markets for VX-01.

“Trial locations were selected primarily based on data acceptability to regulatory authorities worldwide, prevalence of the condition, anticipated patient enrolment rates, and high-quality medical research facilities,” he said.

Icon and Novotech are using a variety of enrolment strategies, from online initiatives to study newsletters for the medical and patient advocacy community, to engaging with optometrists’ networks for referrals.

Phase III plans

Diabetic retinopathy affects more than 100 million people worldwide and, Vantage says, is one of the leading causes of blindness among working-age adults.

Most current NPDR treatments — like Vabysmo, Lucentis, and Eylea — are injected into the eye, which makes them unpopular with patients.

This is likely to help Icon and Novotech attract participants to the study, according to Safarian, who said, “The fact that there is no oral treatment for this condition is a big plus for patients participating in the trial.”

Vantage expects data from the Phase II study to be available in two years and has plans to move VX-01 into late phase trials shortly afterwards, according to Safarian.

“Phase III would tentatively start mid-2027. The same CROs may or may not be selected. It will depend on the scope of the planned Phase III program at the time,” he said.

DepositPhotos/VadimVasenin